Hot Off the Press: Final Rules on CGMPs and Preventive Controls for Human and Animal Food

FDA released pre-publication versions of the two final rules on current good manufacturing practice and preventive controls requirements – one governing human food (here), and the other animal food (here). The pre-publication versions total over 1,500 pages, so will take a while to digest. To help that process along, FDA has issued fact sheets summarizing the rules’ principal requirements (see here and here), and has scheduled webinars in mid-September and a public meeting scheduled to take place in Chicago on October 20. In addition, the agency indicated that several guidance documents are forthcoming.

For human food, larger businesses will be expected to comply with CGMP requirements and most preventive control requirements by September 19, 2016, whereas small and very small businesses will have until September 18, 2017, and September 17, 2018, respectively. However, under certain circumstances, FDA is allowing additional time for compliance with the supply chain program requirements of the rule. For animal food, larger businesses will be expected to comply with CGMP requirements by September 19, 2016, and with most preventive controls requirements by September 18, 2017; small businesses will have an additional year after these dates, and very small businesses will have an additional two years after these dates. FDA is also allowing additional time for compliance with the supply chain program requirements of the animal food rule, under certain circumstances. The range of potentially applicable compliance dates is sufficiently complicated that FDA summarized them in tables included in the final rules (see p. 770 of the human food rule and pp. 556-557 of the animal food rule).

As we work our way through the final rules, we’ll highlight issues that catch our eye.